Final analysis of 379 pregnancy outcomes after exposure to dimethyl fumarate in a prospective international registry.
Mult Scler
; 30(2): 209-215, 2024 Feb.
Article
in En
| MEDLINE
| ID: mdl-38166480
ABSTRACT
BACKGROUND:
Dimethyl fumarate (DMF) has a favorable benefit-risk profile treating people with multiple sclerosis and should be used in pregnant women only if the potential benefits outweigh potential risks to the fetus.OBJECTIVE:
Assess pregnancy outcomes in a completed international registry (TecGistry) of women with MS exposed to DMF.METHODS:
TecGistry included pregnant women with MS exposed to DMF, with data collected at enrollment, 6-7 months gestation, 4 weeks after estimated due date, and at postpartum weeks 4, 12, and 52. Outcomes included live births, gestational size, pregnancy loss, ectopic/molar pregnancies, birth defects, and infant/maternal death.RESULTS:
Of 397 enrolled, median (range) age was 32 years (19-43). Median (range) gestational week at enrollment was 10 (0-39) and at first DMF exposure was 1 (0-13). Median (range) duration of gestational DMF exposure was 5 weeks (0-40). Fifteen (3.8%) spontaneous abortions occurred. Of 360 (89.1%) live births, 323 were full term and 37 were premature. One neonatal death and no maternal deaths occurred. Adjudicator-confirmed EUROCAT birth defects were found in 2.2%.CONCLUSION:
DMF exposure during pregnancy did not adversely affect pregnancy outcomes; birth defects, preterm birth, and spontaneous abortion were in line with rates from the general population.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Abortion, Spontaneous
/
Premature Birth
Type of study:
Observational_studies
/
Risk_factors_studies
Limits:
Adult
/
Female
/
Humans
/
Infant
/
Newborn
/
Pregnancy
Language:
En
Journal:
Mult Scler
Journal subject:
NEUROLOGIA
Year:
2024
Document type:
Article
Affiliation country: